List of Excipients in Branded Drug UP AND UP CHILDRENS IBUPROFEN

« Back to Dashboard

Generic Drugs Containing UP AND UP CHILDRENS IBUPROFEN

Company	Ingredient	NDC	Excipient
Target Corporation	ibuprofen	11673-166	ANHYDROUS CITRIC ACID
Target Corporation	ibuprofen	11673-166	FD&C RED NO. 40
Target Corporation	ibuprofen	11673-166	GLYCERIN
Target Corporation	ibuprofen	11673-166	HIGH FRUCTOSE CORN SYRUP
Target Corporation	ibuprofen	11673-166	HYPROMELLOSE
Target Corporation	ibuprofen	11673-166	POLYSORBATE 80
Target Corporation	ibuprofen	11673-166	SODIUM BENZOATE

What are the Most Frequently-Used Excipients in UP AND UP CHILDRENS IBUPROFEN?

# Of NDCs	Excipient
2	ACESULFAME POTASSIUM
1	AMMONIUM GLYCYRRHIZATE
2	ANHYDROUS CITRIC ACID
2	ASPARTAME
2	CARNAUBA WAX
2	CROSCARMELLOSE SODIUM
1	D&C RED NO. 27 ALUMINUM LAKE

Up & Up Children’s Ibuprofen Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Up & Up Children’s Ibuprofen competes as a store-brand, over-the-counter oral suspension built around a mature active ingredient: ibuprofen 100 mg per 5 mL. Its commercial value depends less on active-ingredient exclusivity than on taste, dosing accuracy, shelf stability, child-appropriate excipients, packaging, and retail economics. The strongest opportunities are sugar-free and dye-free reformulations, differentiated flavor systems, lower-mess delivery devices, and contract-manufacturing platforms that support multiple private-label customers.

What is Up & Up Children’s Ibuprofen?

Up & Up Children’s Ibuprofen is Target’s private-label pediatric ibuprofen product. The relevant dosage form is generally an oral suspension or liquid containing 100 mg of ibuprofen per 5 mL, equivalent to 20 mg/mL. FDA OTC labeling for children’s ibuprofen relies on age- and weight-based dosing and requires a calibrated dosing device for liquid products (FDA, 2024a).

The product is not positioned as an innovative ibuprofen molecule. It is a retail-brand version of a mature OTC analgesic and antipyretic. Product economics therefore depend on:

Commercial variable	Relevance
Active ingredient	Commodity ibuprofen with multiple qualified sources
Excipient system	Controls taste, viscosity, suspension stability, preservative performance, and consumer acceptance
Packaging	Determines dosing accuracy, leakage, tamper evidence, and shelf presentation
Manufacturing	Requires uniform suspension, validated fill volumes, and microbial control
Retail placement	Target distribution and private-label pricing drive volume
Regulatory route	Typically OTC monograph compliance rather than an innovative NDA
Patent position	Limited molecule-level risk; formulation and manufacturing claims require product-specific review

The exact inactive-ingredient profile can vary by flavor, bottle size, manufacturer, and label revision. A commercial diligence review should tie every conclusion to the applicable National Drug Code and current DailyMed or package label.

What excipients are used in children’s ibuprofen suspension?

A conventional pediatric ibuprofen suspension uses excipients from several functional classes. Label-specific compositions commonly include purified water, sweeteners, viscosity modifiers, flavoring agents, buffering agents, preservatives, and wetting or suspending aids.

Excipient class	Typical examples in pediatric oral suspensions	Commercial function
Vehicle	Purified water	Carries the active ingredient and excipients
Sweetener	Sucrose, sorbitol, or other polyol systems	Masks ibuprofen bitterness
Viscosity modifier	Xanthan gum or comparable polymer	Keeps ibuprofen suspended and improves pour control
Wetting agent	Polysorbate 80 or related surfactant	Improves powder wetting and dispersion
Preservative	Sodium benzoate or another permitted preservative	Controls microbial growth in a multidose aqueous product
Buffer	Citric acid, sodium citrate, or related system	Controls pH and supports preservative performance
Humectant or cosolvent	Glycerin or propylene glycol	Improves mouthfeel, solubilizes flavor components, and manages water activity
Flavor	Berry, grape, or other child-oriented flavor	Reduces sensory rejection
Colorant	Product-specific permitted color	Supports product identification and flavor signaling

Ibuprofen has poor water solubility. A suspension therefore must keep micronized or finely milled ibuprofen particles uniformly dispersed rather than dissolve the entire dose. The excipient system must balance sedimentation control against pourability. Excessive viscosity may improve physical stability but can increase residual bottle hold-up, slow dosing, and reduce dose reproducibility.

FDA’s Inactive Ingredient Database provides a reference point for excipient use in approved drug products, but it does not replace review of the specific OTC label or manufacturing formula (FDA, 2024b).

How does the excipient system affect product performance?

Taste masking

Ibuprofen has a strong bitter taste. Sweeteners alone may not provide adequate masking because bitterness can remain after swallowing. A commercial formulation usually combines:

• High-intensity or bulk sweetening
• Fruit flavor
• Viscosity enhancement
• Controlled pH
• Limited surfactant levels
• Reduced oral coating and aftertaste

Flavor selection can materially affect repeat purchase. Berry and grape profiles are common, but a flavor that performs well in sensory testing may not remain stable over the labeled shelf life. Flavor oxidation, interaction with preservatives, and changes in pH can alter the consumer experience.

Suspension stability

The principal technical challenge is maintaining dose uniformity throughout the bottle. Important variables include particle size, density difference between ibuprofen and the vehicle, polymer concentration, mixing energy, and bottle geometry.

A formulation that settles rapidly can produce underdosing at the beginning and overdosing after sediment compacts and is redispersed. The label instruction to shake well is necessary but does not eliminate the need for robust sedimentation and redispersion testing.

Pourability and dosing accuracy

Children’s liquid medicines are commonly administered with oral syringes, cups, or spoons. A product that is too thin can spill and create dosing errors. A product that is too thick can cling to the dosing device or bottle neck.

The most commercially useful rheology is usually shear-thinning: relatively stable at rest, but easier to pour or withdraw under applied force. The formulation should be tested with the intended dosing syringe, not only with laboratory viscometers.

Microbial control

Aqueous multidose products require an effective preservation strategy, suitable container closure, and validated manufacturing controls. Preservative performance depends on pH, water activity, excipient compatibility, microbial challenge results, and container design.

A sugar-containing formula can create additional formulation and microbial-control considerations. Sugar-free systems may improve positioning for caregivers who avoid added sugar, but polyols can introduce gastrointestinal tolerability issues at higher exposure levels.

What formulation opportunities exist for Up & Up Children’s Ibuprofen?

Sugar-free and reduced-sugar products

A sugar-free or reduced-sugar version could target caregivers seeking lower sugar exposure. The main technical tradeoffs are:

• Bitter taste may become more apparent without sucrose body and sweetness.
• Sorbitol or other polyols can affect gastrointestinal tolerability.
• High-intensity sweeteners may create lingering aftertaste.
• Flavor and polymer levels may need adjustment.
• The finished product must retain acceptable viscosity and redispersion.

A "no added sugar" claim requires careful review of the full formulation and labeling language. It should not imply suitability for every dietary or medical condition without substantiation.

Dye-free formulations

Dye-free pediatric medicines address caregiver concerns about artificial colorants and may reduce formulation complexity. The commercial benefit is strongest when paired with clear front-panel communication and a flavor system that remains recognizable without color.

Dye removal can also reduce colorant-related compatibility work. It does not, however, eliminate the need for stability, photostability, and sensory testing.

Alcohol-free and low-excipient positioning

Parents often prefer pediatric products without ethanol, unnecessary dyes, or excessive excipient complexity. A simplified excipient system can support marketing, but each removed ingredient may shift technical burden to another component. For example, reducing cosolvent may affect flavor solubility; reducing surfactant may impair wetting; reducing polymer may impair suspension stability.

Improved flavor and mouthfeel

The highest-value reformulation opportunity may be sensory rather than chemical. Potential approaches include:

• Better bitterness suppression
• Lower aftertaste
• Reduced chalkiness
• Faster mouth clearance
• Flavor systems designed for younger children
• Separate flavor variants by age segment

Taste testing should include children where ethically and operationally appropriate, as well as adult caregivers who administer the dose. Adult acceptability alone is not a reliable proxy for pediatric acceptance.

Higher-concentration products

A more concentrated product could reduce administered volume. That may improve adherence for older children, but it increases dosing risk if caregivers confuse concentrations across products. Any concentration change requires prominent labeling, calibrated dosing devices, and careful evaluation of medication-error risk.

A higher-concentration product also changes suspension rheology, flavor load, dose uniformity, and the risk of bottle-to-bottle sedimentation differences.

What FDA regulatory status applies to children’s ibuprofen?

Children’s ibuprofen is generally regulated as an OTC drug under the FDA’s monograph framework for internal analgesic, antipyretic, and antirheumatic products. The relevant rule is 21 C.F.R. part 343, subject to later monograph amendments and applicable FDA OTC requirements (Electronic Code of Federal Regulations, 2024).

The product must comply with requirements covering:

• Active ingredient identity and concentration
• Indications and warnings
• Age-based dosing
• Drug Facts labeling
• Packaging and tamper evidence
• Manufacturing under current good manufacturing practice
• Stability and expiration dating
• Product quality and dose uniformity

The excipients do not receive independent OTC approval merely because they appear in another product. Their safety, concentration, functionality, and use in the dosage form must be supported by the applicable regulatory framework and manufacturing records.

What is the Orange Book status of Up & Up Children’s Ibuprofen?

Up & Up Children’s Ibuprofen is generally expected to be an OTC monograph product rather than an NDA product listed in the Orange Book. The Orange Book primarily identifies approved drug applications and patent or exclusivity information associated with those applications (FDA, 2024c).

This distinction affects competitive strategy:

Issue	Relevance to Up & Up ibuprofen
Orange Book patent listing	Usually not the principal competitive barrier for a monograph OTC product
Paragraph IV challenge	Typically not the main pathway for a compliant OTC monograph product
Active-ingredient exclusivity	None of practical commercial significance for ibuprofen
Formulation patents	Possible, but must be tied to a specific claimed formulation or process
Regulatory barrier	Monograph compliance, quality systems, and manufacturing validation
Commercial barrier	Retail access, cost, supply reliability, packaging, and consumer preference

An exact patent conclusion requires review of the specific manufacturer, NDC, label, and any associated FDA application. No molecule-level exclusivity should be assumed for ibuprofen.

What patents protect children’s ibuprofen formulations?

The ibuprofen active ingredient is long-established and does not provide meaningful new-molecule exclusivity. Potential intellectual-property protection could instead concern:

• Specific suspension compositions
• Particle-size distributions
• Taste-masking systems
• Controlled-release delivery
• Stabilized ibuprofen polymorphs
• Manufacturing or milling processes
• Container-closure systems
• Dosing devices
• Combination products

For a conventional immediate-release pediatric suspension, formulation patents are more likely to create design-around questions than broad blocking rights. A freedom-to-operate review should search claims covering the exact combination of ibuprofen, suspending polymer, surfactant, preservative, sweetener, pH range, and process conditions.

Patent strength is usually highest where claims require a narrow, measurable formulation feature linked to a demonstrated performance benefit. It is weaker where claims broadly recite standard excipients that are widely used across OTC suspensions.

When does Up & Up Children’s Ibuprofen lose exclusivity?

Up & Up Children’s Ibuprofen does not have a conventional branded-drug exclusivity cliff comparable to a patented prescription product. Ibuprofen is available from many manufacturers, and competing products can enter under the OTC monograph framework if they satisfy the applicable requirements.

Commercial protection comes from:

• Target’s private-label relationship
• Supplier qualification
• Retail shelf placement
• Cost and manufacturing scale
• Flavor and formulation acceptance
• Packaging differentiation
• Supply continuity
• Brand trust

A competitor can generally launch a comparable ibuprofen product without waiting for expiration of an Up & Up-specific molecule patent. The practical risk is share erosion rather than a legally defined generic-entry date.

Which companies compete with Up & Up Children’s Ibuprofen?

The competitive set includes national brands, pharmacy private labels, mass-retail store brands, and online sellers. Relevant competitors include:

• Children’s Motrin
• Advil Children’s
• Walmart store-brand children’s ibuprofen
• CVS Health children’s ibuprofen
• Walgreens children’s ibuprofen
• Rite Aid and regional pharmacy brands
• Amazon private-label or marketplace products
• Perrigo-manufactured private-label products
• Other contract-manufactured OTC brands

National brands may command a premium through recognition, while private labels compete on price. The product with the lowest unit cost does not necessarily have the strongest economics if it produces poor taste acceptance, dosing complaints, leakage, or retailer returns.

What manufacturing and IP barriers affect commercial expansion?

The principal barriers are operational rather than molecule-based.

Manufacturing barriers

A supplier must control:

• Ibuprofen particle size and raw-material consistency
• Suspension uniformity
• High-shear mixing and scale-up behavior
• Preservation and microbial limits
• Fill-volume accuracy
• Bottle and closure compatibility
• Dosing-device fit
• Stability under temperature excursions
• Flavor and color consistency
• Supply of pharmaceutical-grade excipients

A reformulation may require new process validation, stability data, packaging qualification, label review, and retailer approval. Those costs can outweigh the ingredient cost savings of a minor excipient change.

Intellectual-property barriers

Risk areas include patented taste-masking technologies, specialty polymers, device patents, manufacturing processes, and third-party flavor technologies. Standard excipients such as purified water, glycerin, common sweeteners, xanthan gum, citrate buffers, and widely used preservatives generally provide limited standalone differentiation.

What licensing deals could create commercial opportunities?

The most attractive licensing targets are not likely to involve ibuprofen itself. They are more likely to involve enabling technologies:

• Pediatric taste-masking platforms
• Sugar-free flavor systems
• Rapidly redispersible suspension technology
• Unit-dose or syringe-compatible packaging
• Child-resistant, caregiver-friendly closures
• Stability-enhancing particle engineering
• Excipient systems with published pediatric safety support

A license is commercially justified when it produces a measurable benefit in sensory acceptance, dose accuracy, shelf life, manufacturing yield, or reduced excipient burden. A proprietary flavor alone may not support a premium unless it produces a defensible consumer or retailer benefit.

What generic launch risks exist for Up & Up Children’s Ibuprofen?

Generic launch risk is high at the active-ingredient level because ibuprofen is mature, widely available, and not dependent on a single patent holder. The more meaningful risks are:

1. Retailer substitution by another private-label supplier.
2. Price compression among store brands.
3. Loss of shelf space to national brands during promotions.
4. Supply disruption caused by raw-material or packaging constraints.
5. Product recall linked to contamination, fill volume, or labeling.
6. Negative consumer response to taste or dosing-device performance.
7. Confusion caused by multiple ibuprofen concentrations.

A differentiated excipient strategy can reduce substitution risk, but it cannot create durable exclusivity unless supported by enforceable intellectual property, a strong retail relationship, or a clear consumer preference.

Key Takeaways

• Up & Up Children’s Ibuprofen is a mature OTC private-label product whose value is driven by formulation execution and retail economics.
• The core technical problem is maintaining a palatable, stable, accurately dosed ibuprofen suspension.
• The strongest excipient opportunities are sugar-free, dye-free, better-tasting, lower-aftertaste, and more easily redispersed formulations.
• No meaningful molecule-level patent barrier protects conventional pediatric ibuprofen.
• The product is generally associated with OTC monograph compliance rather than Orange Book exclusivity.
• Manufacturing validation, microbial control, dosing-device performance, and supply reliability are more important commercial barriers than active-ingredient patents.
• Taste-masking technology, pediatric delivery systems, and low-excipient formulations offer the clearest licensing opportunities.
• Generic and private-label entry risk is structurally high, making retailer access and consumer acceptance central to revenue protection.

FAQs About Up & Up Children’s Ibuprofen Excipient Strategy

Is Up & Up Children’s Ibuprofen sugar-free?

The answer depends on the specific flavor and label version. Children’s ibuprofen products may use sucrose, sorbitol, or another sweetening system. The current package Drug Facts panel controls the applicable answer.

Why does children’s ibuprofen need a suspending agent?

Ibuprofen has limited water solubility. A suspending agent helps keep solid ibuprofen particles distributed throughout the liquid so that the administered dose is more consistent after shaking.

Can a private-label ibuprofen product use the same excipients as a national brand?

Yes, provided the formulation complies with applicable FDA requirements and the manufacturer avoids third-party patent, trade-secret, trademark, and formulation restrictions.

Is a higher concentration of children’s ibuprofen commercially attractive?

It can reduce dosing volume, but it increases medication-error risk and requires prominent concentration labeling, compatible dosing devices, and stronger caregiver education.

What is the most defensible differentiation for a children’s ibuprofen private label?

The strongest defensible position usually combines superior taste, reliable suspension performance, accurate dosing, child-resistant packaging, and retailer-specific supply execution. Standard excipients alone rarely create durable differentiation.

References

Electronic Code of Federal Regulations. (2024). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. https://www.ecfr.gov/

U.S. Food and Drug Administration. (2024a). OTC pediatric liquid drug products containing ibuprofen: Drug Facts labeling and dosing requirements. https://www.fda.gov/

U.S. Food and Drug Administration. (2024b). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/

U.S. Food and Drug Administration. (2024c). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

U.S. Pharmacopeia. (2024). United States Pharmacopeia and National Formulary. United States Pharmacopeial Convention.